Idiopathic Pulmonary FibrosisPhase 1NCT02871401
A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1 study testing Valganciclovir in people with Idiopathic Pulmonary Fibrosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The investigators will conduct a single-center, prospective, randomized, placebo-controlled, double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 31 Jan 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >21 and <80 years
- ability to provided informed consent
- diagnosis of probable or definite IPF according to American Thoracic Society (ATS) criteria
- tolerance of full-dose (2403 mg/day) pirfenidone
- Positive serology for EBV or CMV
Who cannot join
- FVC < 40% predicted
- Diffusing capacity for carbon monoxide (DLCO) < 35% predicted (Crapo)
- Forced expiratory volume (FEV)1/FVC <0.7
- Significant centrilobular emphysema (>40% by HRCT)
- Active tobacco use (cigarette or cigar smoking)
- Resting oxygen saturation (SpO2) on room air <89%
Show all 31Show fewer
- Listed for lung transplantation defined as being assigned a lung allocation score
- environmental exposure (occupational, environmental, drug, etc.) felt by the principal investigator (PI) to be the etiology of the interstitial disease
- diagnosis of collagen-vascular conditions (according to the published American College of Rheumatology criteria)
- history of unstable or deteriorating cardiac disease
- acute coronary syndrome, coronary artery bypass, or angioplasty within 3 months of screening
- uncontrolled arrhythmia
- uncontrolled hypertension
- known HIV or hepatitis C
- known cirrhosis or chronic active hepatitis
- active substance or alcohol abuse
- pregnancy or lactation
- Women of childbearing potential who are not using a medically approved means of contraception. Subjects will be considered of childbearing potential if they are not surgically sterile or have not been postmenopausal for at least 2 years [any subject who is postmenopausal for < 2 years will be required to have a follicle-stimulating hormone (FSH) level to assess her potential to become pregnant
- clinically relevant lab abnormalities (obtained within 30 days before enrollment), including:
- creatinine > 2 x upper limit of normal (ULN)
- hematology outside of specified limits: white blood cells (WBCs) < 3,500/mm3; hematocrit < 25% or > 59%; platelets < 100,000/mm3;
- total bilirubin > 2 x ULN
- Aspartate (AST) or alanine aminotransferases (ALT)/ serum glutamic-oxaloacetic; transaminase (SGOT), or serum glutamic pyruvic transaminase (SGPT) > 2.0 x ULN
- alkaline phosphatase > 3 x ULN
- albumin < 3.0 mg/dL at screening
- known hypersensitivity to study medication
- any condition that, in the judgment of the PI, might cause participation in this study to be detrimental to the subject or that the PI deems makes the subject a poor candidate
- any therapy with immunosuppressants such as prednisone, azathioprine, or mycophenolate currently or anticipated to be needed during the study period (subjects on these drugs prior to the study will require a 30-day washout period before randomization)
- participation in another IPF clinical treatment trial during the study period (if completing another IPF clinical treatment trial, then a 30-day washout period is required before randomization)
- requirement for chronic suppressive therapy with valacyclovir for recurrent herpes virus infection
- History of myelodysplasia, aplastic anemia, refractory anemia, or multiple myeloma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
The investigators will conduct a single-center, prospective, randomized, placebo-controlled, double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability will be determined by type, frequency and duration of adverse events (AEs) and serious adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon completion of treatment (12 weeks). Subjects will then be followed up at routine clinic visits at 6, 9 and 12 months for data collection.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Valganciclovir, Placebo
- Keywords
- IPF, Herpesvirus, Valganciclovir
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called Valcyte
Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
PlaceboDrug
Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir | Experimental | Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks Receives: Drug: Valganciclovir |
| Placebo | Placebo comparator | Placebo, 2 pills by mouth one time per day x 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
Proportion of study subjects who discontinue study drug due to adverse events
Measured: 12 weeks
Secondary outcomes (3)
Adverse Events - Number
Number of subjects with each reported adverse event
Measured: 12 weeks
Serious Adverse Events
Number of subjects with each serious adverse event
Measured: 12 weeks
Total # Adverse Events
Total number of adverse events
Measured: Randomization to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start3 Jan 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Jonathan Kropski, Vanderbilt University
- Investigators
- Jonathan A Kropski, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871401
- Sponsor's protocol ID
- 160693
- Status last verified
- Apr 2022
- First submitted
- 15 Aug 2016
- Last updated
- 29 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blackwell TS, Hewlett JC, Mason WR, Martin S, Del Greco J, Ding G, Wu P, Lancaster LH, Loyd JE, Dudenhofer RB, Salisbury ML, Kropski JA. A Phase I Randomized, Controlled, Clinical Trial of Valganciclovir in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Aug;18(8):1291-1297. doi: 10.1513/AnnalsATS.202102-108OC.
PubMed 33740394
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02871401
- Acronym / sponsor ID
- 160693
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, Herpesvirus, Valganciclovir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 29 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a single-center, prospective, randomized, placebo-controlled, double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability will be determined by type, frequency and duration of adverse events (AEs) and serious adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon completion of treatment (12 weeks). Subjects will then be followed up at routine clinic visits at 6, 9 and 12 months for data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir | Experimental | Drug: ValganciclovirValganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 2 pills by mouth one time per day x 12 weeks |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >21 and <80 years
- ability to provided informed consent
- diagnosis of probable or definite IPF according to American Thoracic Society (ATS) criteria
- tolerance of full-dose (2403 mg/day) pirfenidone
- Positive serology for EBV or CMV
Key exclusion criteria (31 listed)
- FVC < 40% predicted
- Diffusing capacity for carbon monoxide (DLCO) < 35% predicted (Crapo)
- Forced expiratory volume (FEV)1/FVC <0.7
- Significant centrilobular emphysema (>40% by HRCT)
- Active tobacco use (cigarette or cigar smoking)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValganciclovirAlso: ValcyteSubjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks. | Drug | Valganciclovir |
| PlaceboSubjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks. | Drug | Placebo |
Primary outcome
Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
Time frame: 12 weeks
Proportion of study subjects who discontinue study drug due to adverse events
3 secondary outcomes
Adverse Events - Number
Time frame: 12 weeks
Serious Adverse Events
Time frame: 12 weeks
Total # Adverse Events
Time frame: Randomization to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33740394Blackwell TS, Hewlett JC, Mason WR, Martin S, Del Greco J, Ding G, Wu P, Lancaster LH, Loyd JE, Dudenhofer RB, Salisbury ML, Kropski JA. A Phase I Randomized, Controlled, Clinical Trial of Valganciclovir in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Aug;18(8):1291-1297. doi: 10.1513/AnnalsATS.202102-108OC.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan A Kropski, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valganciclovir in people with Idiopathic Pulmonary Fibrosis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.